Validation and qualification for analytical methods and equipment are required by many regulations, quality standards and company policies. If executed correctly, they can also help to improve the reliability, consistency and accuracy of analytical data. This course guides analyst, laboratory managers and quality assurance managers through the validation and qualification processes in analytical laboratories. The course takes into account most national and international regulations and quality standards. Participants of this course will learn how to speed up their validation and qualification process, thereby avoiding troublesome reworking and gaining confidence for audits and inspections. The validation and qualification procedures presented in this course help to ensure compliance and quality but with minimal extra cost and administrative complexity. The purpose of this course is to answer the key question regarding validation: How much validation is needed and how much is sufficient? The recommendations are complementary rather than contradictory to any standards or official guidelines. They are based mainly on common sense and can be used in cases where information from official guidelines and standards is insufficient for day-to-day work.
Upon the successful completion of this course, each participant will be able to: -
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- Apply and gain an in-depth knowledge on data and method validation in analytical laboratories
- Assess how much validation is needed and how much is sufficient
- Discuss the regulations, quality standards and guidelines pertaining to national and international organizations that includes ISO, EN and US
- Carryout the recommended protocols and steps for the qualifications in design, preinstallation & installations of systems, operations, performance and maintenance
- Recognize parametric statistics and summarizing data as well as statistical analysis of raw data
- Perform T-testing and F-testing and identify linear regression, anova, quality control and charting
- Explain the validation of analytical methods including the validation of standard and non-routine methods, quality control plans, revalidation and parameters for methods validation
- List various examples of method validation and perform proficiency testing for external laboratory qualification
- Describe measurement uncertainty and employ proper auditing
DAY 1
Regulations, Standards & Guidelines (USA, EN and ISO)
- Overview
- Specific Regulations and Guidelines
- Specific Quality Standards
- and Guidelines
- Guidance Documents of National and International
- Organizations
- How to Deal with Multiple Regulations and Quality
- Standards
- Summary Recommendations
Installation Qualification & Operational Qualification
- Preinstallation
- Installation
- Tests During Installation
- The Installation Qualification Protocol
- Requalification after Changes to the Systems
- Considerations
- Documentation
- A Practical and Economical Approach for Implementation
- System Suitability Testing
- Handling of Defective Instruments
- Summary Recommendations
Performance Qualification & Maintenance
- Logbook
- Maintenance
- Calibration
- Performance Testing
Parametric Statistics & Summarising Data
- Distributions of Data
- Standard Deviation
- Summarising Data
DAY 2
Statistical Analysis of Raw Data
- Outlier Testing
- Dixon Test
- Grubbs Test
T-testing & F-testing
- Hypothesis Testing
- The T-test
- One Sample T-test
- Two Sample T-test
- Paired Comparison T-test
- The F-test
Linear Regression & ANOVA
- The Calibration Process
- Correlation Coefficient
- Residuals Regression
- Coefficients
- Prediction Intervals
- Standard Error of Prediction Anova Analysis
DAY 3
Quality Control & Charting
- Introduction
- QC Sample Types
- Shewart Charts
- Range Charts
- Moving Average Charts
- Chart Rules and Interpretation
Validation of Analytical Methods
- Introduction
- Strategy for the Validation of Methods
- Validation of Standard Methods
- Validation of Nonroutine Methods
- Quality Control Plan
- Implementation to Routine Analysis
- Revalidation
- Parameters for Method Validation
- Summary Recommendations
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DAY 4
Example Method Validation
- Purpose
- Scope
- Acceptance Criteria
- System Suitability
- Example Method Validation
Proficiency Testing for External Laboratory Qualification
- Procedure
- Evaluation of Proficiency Testing
- Who Should Participate in Proficiency Testing
- Frequency of Tests
- Testing Material
- Advantages for Laboratories
- Performance Improvements
- Remaining Issues
- Summary Recommendations
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DAY 5
Measurement Uncertainty
- Introduction to ISO 17025 Requirements
- Standard Uncertainty Expanded
- Uncertainty Precision and Bias
Audits
- Audit Report
- Audit Checklist
- Summary Recommendations
This course provides an overview of all significant aspects and considerations of data and method validation in analytical laboratories for quality managers, quality, professionals, laboratory managers, superintendents, supervisors, chemists, scientists, analysts and other technical staff.